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Welcome to OncologyPRO, the home of ESMO’s educational and scientific resources, with Guidelines, a comprehensive list of E-Learning modules, Factsheets on biomarkers, slides and webcasts from our educational programme, and more... to support continuing medical education and daily practice!

Previously enzalutamide, an orally administered androgen receptor inhibitor, showed improved OS in men with mCRPC who had received prior docetaxel. The PREVAIL study examined whether enzalutamide could prolong OS and rPFS (co-primary endpoints and analysed for the intent-to-treat population) in asymptomatic or mildly symptomatic chemotherapy-naive patients with mCRPC.

The study results

Patients were stratified by site and randomised 1:1 to enzalutamide or placebo. A total of 1,717 men were randomised (1,715 treated) between September 2010 and September 2012. The interim analysis at 539 deaths showed a statistically significant benefit of enzalutamide over placebo with a 30% reduction in risk of death (OS, p < 0.0001) and an 81% reduction in risk of radiographic progression or death (rPFS, p < 0.0001).

At the time of the analysis, 28% of enzalutamide patients and 35% of placebo patients had died. Estimated median OS was 32.4 months in the enzalutamide arm vs. 30.2 months in the placebo arm. Median rPFS was not yet reached in the enzalutamide arm vs. 3.9 months in the placebo arm.

Enzalutamide treatment delayed the need for chemotherapy by a median of 17 months. Median time to chemotherapy was 28 months in the enzalutamide group vs. 10.8 months in the placebo arm (p < 0.0001).

Enzalutamide was well tolerated with the most common side effects being fatigue, constipation, and back and joint pain (mostly grade 1), as well as common side effects of hormone therapy (e.g. weight gain and hot flashes). Grade 3 or higher adverse events were reported in 43% of the enzalutamide group vs. 37% of the placebo group. Seizure events were reported in two patients. Six percent of patients in both arms discontinued treatment due to adverse events.

At an interim analysis in October 2013, the Independent Data Monitoring Committee considered the benefit-risk ratio to favour enzalutamide and recommended stopping the study and crossing placebo patients to enzalutamide.

Enzalutamide is currently approved for mCRPC progressing on docetaxel. Further studies are needed to compare head-to-head in randomised trials enzalutamide with abiraterone in the pre-chemotherapy disease setting and to study sequencing and combinations of newer agents.